NCT01404351撤回不适用
A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade® 4.0 in Bilateral Breast Reduction
Medtronic Surgical Technologies2 个研究点 分布在 1 个国家开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Difference in pain
研究概览
简要总结
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade® 4.0 during bilateral breast reduction; to monitor and record post-operative pain, adverse events and skin scarring following surgery; and to compare these outcomes to the HARMONIC SYNERGY® BLADE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70
- •Physically healthy, stable weight
- •No smoking <1 month prior to surgery and during study.
- •Desiring bilateral breast reduction
- •Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
- •Subject must be willing and able to comply with specified follow-up evaluations.
- •Female subjects must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the study.
排除标准
- •Age younger than 18 or greater than 70 years old
- •Anticoagulation therapy which cannot be discontinued
- •Smoking <1 month prior to surgery or during study
- •Infection (local or systemic)
- •Cognitive impairment or mental illness
- •Severe cardiopulmonary deficiencies
- •Known coagulopathy
- •Immunocompromised
- •Prior history of breast cancer
- •Kidney disease (any type)
- •Currently taking any medication known to affect healing
- •Subjects who are status-post gastric banding or gastric bypass
- •Currently enrolled in another investigational device or drug trial
- •Unable to follow instructions or complete follow-up
结局指标
主要结局
Difference in pain
时间窗: 24 hours and first 10 days post-op
The primary endpoint will be the difference in pain between the Harmonic and PlasmaBlade operative sites. The primary efficacy variable will be pain at each treatment arm operative site, as measured by visual analog scale for 24 hours post-operatively and for 10 post-op days twice daily.
次要结局
- Operative performance(Intraoperatively on day 0)
- Adverse events(1 month post-operatively)
- Cutaneous scarring(Up to one year post-operatively)
研究者
研究点 (2)
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